New drug trial could help relieve the pain of diabetes

French biotech company Pharmaleads is leading a clinical trial of 120 patients which hopes to find an effective and non-addictive drug to relieve diabetic neuropathy.

The trial will be the first of its kind to investigate the potential of an innovative drug (PL37) which can prolong the body’s own natural painkillers.

Dual Enkephalinase Inhibitors (DENKIs) like PL37 are a novel class of analgesics for chronic pain conditions such as diabetic neuropathy.

Each patient will spend approximately 6 weeks in the study, and will have to visit one of 11 study centres in the UK five times during that period as well as call a toll-free telephone number (electronic diary system) daily to record the intensity of his/her pain on a scale of 1 to 10.

To see if you qualify for the trial please complete the form on the right.

The study may be suitable for you if you are:

• Aged from 18-75 years;
• Diagnosed (by a pain specialist or endocrinologist) with peripheral neuropathic pain of diabetic origin;
• Experiencing a significant degree of pain;
• On a stable treatment with pregabalin or gabapentin for at least one month prior to screening visit;
• Willing to use highly effective contraception from screening to one week after end of study treatment;
• On a stable dose of any other treatment you might be on.
• You must have an adequately controlled diabetes (HbA1c below 10% or 86 mmol/mol)

You cannot participate if:

• You suffer from unstable angina, heart failure or severe pulmonary disease requiring home oxygen
• You have serious renal or liver disease
• You suffer from rheumatoid arthritis, inflammatory bowel disease or mechanical low back disorder
• You are taking systematic analgesic, opioids or anti-inflammatory medications (other than paracetamol) or capsaicin cream, during the month prior to screening visit
• You have suffered from recent (last 2 weeks) febrile illness
• You have difficulty swallowing (the study medication will need to be swallowed whole before each meal)
• You are pregnant or breastfeeding
• You are participating in another trial or if you have had another intervention (in the last month)
• You have a history of drug or alcohol abuse
• You suffer from depression

Participating centres

• LIVERPOOL
  The Walton Center NHS Foundation Trust, Liverpool, L9 7LJ
• BIRMINGHAM
  Birmingham Heartlands Hospital, Bordesley Green, East Birmingham, B9 5SS
• ST HELENS
  St Helens Hospital Marshalls Cross Road, St Helens WA9 3DA
• SHEFFIELD
  Sheffield Teaching Hospitals and University of Sheffield Royal Hallamshire Hospital, Glossop Road, Sheffield, S10 2JF
• CHORLEY
  Chorley and South Ribble District Hospital, Chorley, PR7 1PP
• POOLE
  Poole Hospital Foundation Trust, Longfleet Rd, Poole, BH15 2JB
• OLDHAM
  Royal Oldham Hospital, Marjory Lees Unit, Rochdale Road, Oldham, OL1 2JH
• MANCHESTER
  Trafford General Hospital, Moorside Road, Davyhulme, Manchester M41 5SL
• LONDON
  St Thomas' Hospital, Westminster Bridge Road, London, SE1 7EH
• BATH
  Royal United Hospitals Bath NHS Foundation Trust, Combe Park, Bath, BA1 3NG
• BOURNEMOUTH
  Royal Bournemouth Hospital, Castle Lane East, Bournemouth BH7 7DW